Gilead gets FDA nod for new indication for Veklury

The Food and Drug Administration has granted Gilead Sciences approval for the use of Veklury (remdesivir) with no dose adjustments to treat COVID-19 in people with mild, moderate and severe hepatic impairment. This approval further supports the safety profile of Veklury as the first and only approved antiviral COVID-19 treatment that can be used across all stages of liver disease, the company said.

“With the recent increase in levels of COVID-19 circulating in the U.S., the risk to vulnerable individuals persists, including for those with hepatic impairment,” said Frank Duff, senior vice president of virology therapeutic area head at Gilead Sciences. “This approval demonstrates Gilead’s ongoing commitment to COVID-19, including our focus on vulnerable populations.”

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“The update to the safety profile and dosing recommendations for Veklury for those living with liver disease is important to this vulnerable population who faces an increased risk of complications from COVID-19,” said Douglas Dieterich, director of the Institute for Liver Medicine, Professor of Medicine, division of liver diseases at the Icahn School of Medicine at Mount Sinai. “While COVID-19 is no longer a public health emergency, the virus continues to present a threat to those with underlying conditions.”

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